FDA gives warning on antibiotic Ketek

NEWS IN BRIEF — Posted July 24, 2006

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The Food and Drug Administration issued an advisory June 29 to alert physicians and patients to the occurrence of rare but potentially hazardous liver injuries from the drug, Ketek, the first approved antibiotic of the ketolide class.

On the market since 2004, Ketek is used to treat acute exacerbation of chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia of mild to moderate severity, including pneumonia caused by resistant strep infections.

The drug has been associated with rare cases of serious liver injury and liver failure resulting in at least four deaths and one liver transplant.

After a safety assessment, the agency concluded that Ketek's benefit to patients outweighs its risks and supported its continued availability.

Patients who experience signs or symptoms of liver problems, including fatigue, malaise, loss of appetite, nausea, yellow skin and dark-colored urine should discontinue the drug and seek medical evaluation, which could include tests for liver function, said Steven Galson, MD, director of FDA's Center for Drug Evaluation and Research.

The warning is being added to the drug's label.

Note: This item originally appeared at

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